Oxytocin to Decrease Blood Loss During Cesarean Section

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Labib Ghulmiyeh, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT00891150
First received: April 30, 2009
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

The goal of this study is to determine the best dose of a drug called oxytocin, that is usually used to stop bleeding during a delivery, when used during a cesarean delivery. It will be administered during cesarean section in order to decrease the amount blood loss. The investigators are proposing to have 3 groups of subjects each given a different safe dose of oxytocin and then to assess the effectiveness of each regimens on the amount blood lost during cesarean sections.This will let use know which is the best lowest dose needed.


Condition Intervention
Complications; Cesarean Section
Drug: Oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Intravenous Oxytocin Use to Decrease Blood Loss During Cesarean Section. What is the Optimal Dose: A Randomized Blinded Trial

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • The change in hemoglobin as a measure of blood loss. The change in hemoglobin is defined as the difference between the predelivery hemoglobin value and the postpartum value [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The need for blood transfusion and the use of additional uterotonic agents, pad weight, pad count, estimated blood loss. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oxytocin
group 1 will receive oxytocin solutions with 20U/500ml during cesarean section
Drug: Oxytocin

Pre-mixed, oxytocin solutions with either 20U/500ml, 30U/500ml or 40U/500ml of Lactated Ringer's solution will be available in the pharmacy department. The bags will be identical in appearance. Each bag will be labeled with a study identification number, from which the pharmacy could determine the administered dose. Subjects as well as the medical providers will be blinded to the assignment of the solution used.

Immediately after delivery of the infant, the study solution will be infused over 30 minutes using a continuous infusion pump (666 mU/min versus 999 mU/min versus 1332mU/min).

Other Name: Pitocin
Active Comparator: oxytocin2
group 2 will receive oxytocin solutions with 30U/500ml during cesarean section
Drug: Oxytocin

Pre-mixed, oxytocin solutions with either 20U/500ml, 30U/500ml or 40U/500ml of Lactated Ringer's solution will be available in the pharmacy department. The bags will be identical in appearance. Each bag will be labeled with a study identification number, from which the pharmacy could determine the administered dose. Subjects as well as the medical providers will be blinded to the assignment of the solution used.

Immediately after delivery of the infant, the study solution will be infused over 30 minutes using a continuous infusion pump (666 mU/min versus 999 mU/min versus 1332mU/min).

Other Name: Pitocin
Active Comparator: oxytocin3
group 3 will receive oxytocin solutions with 40U/500ml during cesarean section
Drug: Oxytocin

Pre-mixed, oxytocin solutions with either 20U/500ml, 30U/500ml or 40U/500ml of Lactated Ringer's solution will be available in the pharmacy department. The bags will be identical in appearance. Each bag will be labeled with a study identification number, from which the pharmacy could determine the administered dose. Subjects as well as the medical providers will be blinded to the assignment of the solution used.

Immediately after delivery of the infant, the study solution will be infused over 30 minutes using a continuous infusion pump (666 mU/min versus 999 mU/min versus 1332mU/min).

Other Name: Pitocin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study subjects will be women delivering via an elective cesarean section at term
  • All study subjects will have singleton gestation with no obstetric or medical complication.

Exclusion Criteria:

  • Laboring women
  • Multifetal gestation
  • Prolonged oxytocin use (>12 hours)
  • Hypertensive disorders
  • Chorioamnionitis
  • Suspected macrosomia
  • Polyhydramnios
  • History of postpartum Hemorrhage
  • Clotting disorder
  • Intake of magnesium sulfate
  • Uterine fibroids
  • Placenta previa
  • Placental abruption
  • Anticoagulation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891150

Locations
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Labib M Ghulmiyyah, MD American University of Beirut Medical Center
  More Information

No publications provided

Responsible Party: Dr. Labib Ghulmiyeh, Assistant Professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT00891150     History of Changes
Other Study ID Numbers: OGY.LB.01
Study First Received: April 30, 2009
Last Updated: March 5, 2013
Health Authority: Lebanon: Institutional Review Board

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014